NCT03627767

Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,235 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

Detailed description

Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.

Conditions

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Diseases
• Skin Diseases, Genetic
• Genetic Diseases, Inborn
• Skin Diseases, Eczematous
• Hypersensitivity
• Hypersensitivity, Immediate
• Immune System Diseases

Interventions

Type	Name	Description
DRUG	PF-04965842 100 mg	PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
DRUG	PF-04965842 200 mg	PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
DRUG	Placebo	Placebo, administered as two tablets to be taken orally once daily for 40 weeks

Timeline

• Start date: 2018-06-11
• Primary completion: 2020-09-02
• Completion: 2020-10-07
• First posted: 2018-08-13
• Last updated: 2021-09-20
• Results posted: 2021-09-20

Locations

235 sites across 21 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Germany, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, Spain, Taiwan

Regulatory

• FDA-regulated drug study